Control module for delivery systems

ABSTRACT

A guidewire is coupled to a control module and extends through a lumen of the control module. The control module operates to transition between a first control state wherein the control module allows movement of the guidewire relative to a catheter and a second control state wherein relative axial movement between the catheter and guidewire is prevented.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of Ser. No. 14/686,159,filed Apr. 14, 2015 which is a non-provisional application of62/048,929, filed on Sep. 11, 2014, entitled “CONTROL MODULE FORDELIVERY SYSTEM,” and of U.S. Patent Application Ser. No. 61/983,560,filed on Apr. 24, 2014, entitled “CONTROL MODULE FOR DELIVERY SYSTEMS,”wherein all of these applications are assigned to the assignee of thepresent application and the entire contents of all of these applicationsare incorporated herein by reference.

BACKGROUND

Currently, replacement of a deficient cardiac valve is often performedby placing the patient under extracorporeal circulation, temporarilystopping the heart, opening the thorax (e.g., by a sternotomy),surgically opening the heart, excising the deficient valve, and thenimplanting a prosthetic valve in its place. This procedure generallyrequires prolonged patient hospitalization, as well as extensive andoften painful recovery.

Recently, minimally invasive approaches have been developed tofacilitate catheter-based implantation of valve prostheses in thebeating heart, intending to obviate the need for the classic sternotomyand cardiopulmonary bypass. For example, U.S. Pat. No. 8,016,877 toSeguin et al. illustrates a technique and a device for replacing adeficient heart valve by percutaneous route. An expandable prostheticvalve can be compressed about a catheter, inserted inside a body lumen,such as the femoral artery, and delivered to a desired location in theheart. Additionally, U.S. Pat. No. 7,914,569 to Nguyen et al. disclosesadvancing a catheter containing a prosthesis in a retrograde mannerthrough the femoral artery and into the descending aorta, over theaortic arch, through the ascending aorta and inside the defective aorticvalve. This procedure can be assisted by fluoroscopic guidance. Once theposition of the catheter containing the prosthesis is confirmed, asheath containing the prosthesis can be moved proximally, allowing thevalve prosthesis to self-expand.

In some current approaches, a guidewire is utilized to guide thecatheter during delivery. The guidewire can be routed through apatient's vasculature to the desired location. Once the guidewire is inplace, the catheter is advanced over the guidewire so as to deploy theprosthesis. During advancement of the catheter and deployment of theprosthesis, management of the guidewire is important so as to preventinadvertent injury to the patient.

SUMMARY

In one example, concepts presented herein relate to a delivery systemhaving a handle. A catheter includes a lumen, a first end coupled to thehandle and a second end coupled to a tip. A control module is coupled tothe tip and a guidewire is coupled to the control module. The controlmodule operates to transition between a first control state wherein thecontrol module allows axial movement of the guidewire relative to thetip and a second control state wherein relative axial movement betweenthe tip and guidewire is prevented.

In another example, a method includes receiving a delivery system havinga proximal handle, a delivery sheath capsule and a tip maintaining acontrol module. The system is loaded with a radially expandable stentframe. The delivery sheath capsule contains the stent frame in acompressed arrangement over an inner shaft assembly. The prostheticheart valve is delivered in the compressed arrangement to animplantation site using a guidewire and the control module is operatedto prevent movement of the guidewire relative to the tip. The methodfurther includes retracting the delivery sheath capsule such that thestent frame can expand to an expanded arrangement.

In yet another example, a stent frame delivery system has a handleincluding at least one actuator. A catheter is coupled to the actuatorand includes a lumen and a delivery sheath capsule compressivelyretaining a stent frame and a tip positioned distal the delivery sheathcapsule. A guidewire is positioned within the handle and the lumen ofthe catheter and a control module is coupled with the tip. The controlmodule controls the guidewire to allow movement of the guidewirerelative to the handle during a first control state and prevent movementof the guidewire relative to the handle during a second control state.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of a delivery system employing a controlmodule for a guidewire.

FIG. 2 is a schematic sectional view of a handle coupled with a controlmodule for a guidewire.

FIG. 3 is a schematic view of a proximal end of a handle coupled with acontrol module for a guidewire.

FIG. 4 is a schematic view of a proximal end of a handle coupled with acontrol module for a guidewire.

FIG. 5 is a schematic view of a control module for a guidewire coupledwith a tip of a delivery system.

FIGS. 6A and 6B are schematic views of a control module for a guidewirecoupled with a tip of a delivery system.

FIGS. 7A and 7B are schematic views of a control module for a guidewirecoupled with a tip of a delivery system.

FIGS. 8A and 8B are schematic views of a control module for a guidewirecoupled with a tip of a delivery system.

FIGS. 9A and 9B are schematic views of a control module for a guidewirecoupled with a tip of a delivery system.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific examples in which the disclosure may bepracticed. It is to be understood that other examples may be utilizedand structural or logical changes may be made without departing from thescope of the present disclosure. The following detailed description,therefore, is not to be taken in a limiting sense, and the scope of thepresent disclosure is defined by the appended claims. It is to beunderstood that features of the various examples described herein may becombined, in part or whole, with each other, unless specifically notedotherwise.

While the disclosure refers to illustrative embodiments for particularapplications, it should be understood that the disclosure is not limitedthereto. Modifications can be made to the embodiments described hereinwithout departing from the spirit and scope of the present disclosure.Those skilled in the art with access to this disclosure will recognizeadditional modifications, applications, and embodiments within the scopeof this disclosure and additional fields in which the disclosed examplescould be applied. Therefore, the following detailed description is notmeant to be limiting. Further, it is understood that the systems andmethods described below can be implemented in many differentembodiments. The operation and behavior of the systems and methodspresented are described with the understanding that modifications andvariations of the embodiments are possible given the level of detailpresented.

References to “one embodiment,” “an embodiment,” “in certainembodiments,” etc., indicate that the embodiment described may include aparticular feature, structure, or characteristic, but every embodimentmay not necessarily include the particular feature, structure, orcharacteristic. Moreover, such phrases are not necessarily referring tothe same embodiment. Further, when a particular feature, structure, orcharacteristic is described in connection with an embodiment, it issubmitted that it is within the knowledge of one skilled in the art toaffect such feature, structure, or characteristic in connection withother embodiments whether or not explicitly described.

The delivery systems disclosed herein can include a moldable handlecapable of translating linear relative movement between multiple shaftssimultaneously to deliver a valve prosthesis. The delivery systems caninclude a two-part prosthesis containment capsule which can maintain acompressible interference fit, mitigating risks associated with snaggingduring retraction of the delivery system. The delivery system handle canbe reversibly decoupled, allowing for rapid closure of the prosthesiscontainment capsule after delivery of the prosthesis. The decouplingmechanism can be user operated and can include a safety feature toprevent premature actuation.

The delivery system can also include a safety stop feature on thehandle, which can permit only partial deployment of one or morecomponents of the valve prosthesis, such as valve prosthesis supportarms, such as by impeding the rotation of a handle support arm knob, toallow repositioning or recapturing of the prosthesis. The user can thenchoose to release the safety stop button to allow the handle support armknob to continue to be rotated until completion of the deployment of oneor more components of the valve prosthesis, such as the deployment ofthe valve prosthesis support arms.

The delivery system can also include a delivery catheter, which can havea two-part valve prosthesis containment capsule divided into distal andproximal portions. To deploy the valve prosthesis, the proximal capsuleportion can be retracted proximally to release one or more portions ofthe valve prosthesis. The distal capsule portion can be advanceddistally to release one or more portions of the valve prosthesis. Afterfull valve prosthesis deployment, the distal and proximal capsuleportions can be returned to their closed, pre-deployment configurationto allow safe removal of the delivery system through the deployedprosthesis.

FIG. 1 illustrates an example delivery system 100, which can include ahandle 200 and a catheter 300. Handle 200 can include front grip 210,rear grip 212, valve release knob 202, support arm knob 204, safety stopbutton 206, handle decoupling button 208, and decoupling portion 209 andguidewire control module 214. Catheter 300 can include outer shaft 302and capsule 304. Capsule 304 can include proximal capsule portion 306,distal capsule portion 308, inner shaft 310, valve containment sleeve312, and capsule tip 314.

Front grip 210 and rear grip 212 can be ergonomically designed tofacilitate grasping of handle 200 by the user. Front grip 210 and reargrip 212 can be made of a moldable material, such as plastic or rubber,which can provide a smooth and frictional gripping surface. Front grip210 and rear grip 212 can include grip flush ports 215, which can beused, for example, to remove air or add fluid to delivery system 100.Rear grip 212 can also include end flush port 230, which can also beused for these purposes, and additionally for inserting surgical toolsthrough handle 200. Support arm knob 204, valve release knob 202, safetystop button 206, and handle decoupling button 208 are all features thatcan be used to deploy a valve prosthesis and then rejoin the capsuleportions 306 and 308 after valve prosthesis deployment.

In certain embodiments, valve containment sleeve 312 can be acylindrical polymer sleeve, configured to retain a valve prosthesiswithin capsule 304. In certain embodiments, capsule tip 314 can be anatraumatic tip to prevent or minimize damage to a patient's organs andvascular system as delivery system 100 is advanced through the patient'sbody. In certain embodiments, capsule tip 314 can include an opening atits distal end to allow delivery system 100 to pass over a guide wire.In certain embodiments, capsule tip 314 can be radiopaque to facilitatelocating delivery system 100 within the body of a patient using medicalimaging.

To facilitate deployment, proximal capsule portion 306 can be retractedin the proximal direction, for example, by rotating support arm knob204, which is coupled to proximal capsule portion 306 through outershaft 302. As such, force placed on outer shaft 302 is translated toproximal capsule portion 306. It is understood that the term support armknob is exemplary. By support arm knob, the disclosure includes knobs,slides, switches and other similar structures that can be activated tocause proximal capsule portion 306 to move axially.

A safety stop feature can be located on handle 200, for example, withinsupport arm knob 204, and can prevent proximal retraction of proximalcapsule portion 306 beyond a predetermined distance. The safety stopfeature can permit only partial deployment of the valve prosthesissupport arms. Medical imaging can be used to determine the location ofthe support arms, and, if not in the proper location, the valveprosthesis can be repositioned or recaptured. Once in the properdeployment location, the user can activate safety stop button 206 onsupport arm knob 204 to allow further proximal retraction of proximalcapsule portion 306. The safety stop button 206 can be a button, switch,knob, or other similar structures that can prevent proximal retractionof proximal capsule portion 306.

Distal capsule portion 308 can be advanced distally, such as by rotatingvalve release knob 202. It is understood that the term valve releaseknob is exemplary. By valve release knob, the disclosure includes knobs,slides, switches and other similar structures that can be activated tocause distal capsule portion 308 to move axially.

Valve release knob 202 can control inner shaft 310, which, in oneembodiment, can be connected to distal capsule portion 308. By advancingdistal capsule portion 308, and thus valve containment sleeve 312, inthe distal direction, the valve prosthesis can be released.

Manual retraction of distal capsule portion 308 can be performed, forexample, by rotating valve release knob 202 in a direction opposite tothe direction that advances distal capsule portion 308. Manualretraction of distal capsule portion 308 can also be performed bypressing handle decoupling button 208, which can decouple decouplingportion 209 of handle 200. The user can then pull decoupling portion 209of handle 200 proximally. This movement can pull the inner shaft 310,which can be connected to distal capsule portion 308, in the proximaldirection, thus retracting distal capsule portion 308 proximally to matewith proximal capsule portion 306. Once capsule 304 is closed, deliverysystem 100 can be safely retracted through the deployed valve prosthesisand removed from the body.

Guidewire control module 214, in one embodiment, can be positioned at aproximal end of handle 200, adjacent rear grip 212. As discussed in moredetail below, a guidewire 400 can be inserted through the handle 200 andcatheter 300 to assist in delivery of the capsule 308. The controlmodule 214 operates to transition between a first control state and asecond control state. In the first control state, the control moduleallows relative movement between the guidewire 400 and the catheter 300.In one particular embodiment, the control module 214 axially moves theguidewire 400 relative to the catheter 300 in the first control state.In the second control state, relative movement between guidewire 400 andthe catheter 300 is prevented.

In certain embodiments, the control module 214 can be coupled to reargrip 212 as illustrated in FIG. 1, or otherwise integrated into thehandle 200 and/or catheter 300 as desired. To effectuate control of theguidewire, the control module 214 may include a lumen for which theguidewire can pass through. In addition, the control module 214 mayinclude one or more mechanisms that engage the guidewire so as toperform one or more of the following: control advancement and retractionof the guidewire with respect to the handle 200 and/or the catheter 300,detect actuation of portions of the handle 200 and/or the catheter 300,detect advancement and retraction of the guidewire with respect to thehandle 200 and/or the catheter 300, lock the guidewire with respect tothe handle 200 and/or the catheter 300 and mechanically feed theguidewire relative to the handle 200 and/or the catheter 300.

With the above features in mind, FIG. 2 is a schematic, sectional viewof a portion of one embodiment of delivery system 100. Control module214 is secured to rear grip 212 with a press or interference fit. Inother embodiments, control module 214 can be connected with a threadedinterface or other mechanism as desired. Control module 214 defines alumen 216 that receives a guidewire 400. In addition, control module 214includes a switch 218 and a locking or clamping mechanism 220. Thelocking mechanism 220 as shown includes opposed jaws positioned oneither side of the guidewire 400. Upon operation of switch 218, lockingmechanism 220 closes, preventing further movement of guidewire 400relative to the control module 214.

During operation, guidewire 400 is inserted through lumen 216 andthrough a luer lock 230 positioned at a proximal end of the handle 200.The guidewire is further inserted into a guidewire shaft seal hub 232that includes an o-ring 234 at its distal end and into a guidewire shaft236. Guidewire shaft 236 is coupled with inner shaft 310, which includesa lumen to receive the guidewire 400. Insertion of the guidewire 400through the inner shaft 310 can lead to tip 314 (FIG. 1). As discussedabove, movement of inner shaft 310 is controlled by knob 202. Inparticular, rotation of knob 202 causes an actuator 240 to move in alinear direction as indicated by arrow 242. This linear movement istranslated to inner shaft 310. Likewise, movement of outer shaft 302 iscontrolled by knob 204. Rotation of knob 204 causes an actuator 244 tomove in a linear direction as indicated by arrow 246. This linearmovement is translated to outer shaft 302.

One feature of control module 214 allows automatic locking of theguidewire 400 in response to movement of either the outer shaft 302 orinner shaft 310. Operation of outer shaft 302 and inner shaft 310 isperformed in deployment of the attached prosthesis. During operation ofthese shafts, it can be desirable to lock guidewire 400 so as to preventinadvertent injury caused by the guidewire 400 to the patient. To thisend, a first sensor 250 is coupled with actuator 240, whereas a secondsensor 254 is coupled with actuator 254. Upon movement of actuator 240,sensor 250 can send a suitable signal to switch 218. In response to thissignal, switch 218 can operate to close locking mechanism 220 so as toprevent further movement of guidewire 400 relative to catheter 300. In asimilar manner, upon movement of actuator 244, sensor 254 can send asuitable signal to switch 218, which operates to close locking mechanism220.

In an alternative embodiment, illustrated in FIG. 3, an alternativeguidewire control module 270 includes switch 218 that operates asdiscussed above. In addition, control module 270 also includes amanually operated switch or actuator 272, an actuating mechanism (e.g.,a motor) 274 and proximal and distal engagement mechanisms 276 and 278,respectively. Motor 274 operates the engagement mechanisms 276 and 278to control the guidewire 400. For example, upon operation of switch 218,motor 274 can operate the engagement mechanisms 276 and 278 to lockguidewire 400 relative to the control module 270.

Motor 274 can also be utilized to advance and/or retract guidewire 400by operating engagement mechanisms 276 and 278, for example in responseto a signal from switch 272. In one embodiment, switch 272 is a toggleswitch capable of providing a signal in both proximal and distaldirections. Regardless of the particular structure for switch 272,engagement mechanisms 276 and 278 can control movement of guidewire 400.In one example, the engagement mechanisms 276 and 278 include opposedwheels that rotate relative to the control module 270. This rotationcauses movement of the guidewire 400 relative to the control module 270based on a direction of rotation of the wheels.

In yet a further embodiment, illustrated in FIG. 4, a control module 280includes an engagement mechanism 282 and a manually operated lockingswitch 284. Engagement mechanism 282 can be coupled to an actuatingmechanism such as a ratchet or motor to move guidewire 400 linearly withrespect to the control module 280. In addition, switch 284 can beoperated to lock guidewire 400 with respect to the control module 280.In one embodiment, the switch 284 is actuated so as to bias opposedwheels of engagement mechanism 282 toward one another. This actuationcauses guidewire 400 to be locked with respect to control module 280.Upon release of the switch, guidewire 400 is able to be advanced and/orretracted relative to the control module 280.

In addition to control of the guidewire 400 proximate the handle 200, adistal end of the guidewire 400 can also be controlled as desired.Several embodiments are discussed below for controlling the distal endof the guidewire 400. For example, these embodiments can be operated toprevent relative movement between portions of the delivery system 100and/or control movement of the distal end relative to portions of thedelivery system 100. In specific instances, the control module allowsrelative movement between tip 314 of the catheter 300 and the guidewire400 in a first control state and prevents relative axial movementbetween tip 314 of the catheter 300 and the guidewire 400 in a secondcontrol state. In one embodiment, the second control state providesincreased strength and stiffness to the tip 314. As a result, retractionof the capsule can be performed with minimal movement of portions of thedelivery system 100, providing increased accuracy for deployment of thestent frame.

In one embodiment, illustrated in FIG. 5, a distal end 402 of theguidewire 400 is positioned within tip 314. A control module 403(referenced generally) includes a first threaded section 404 and asecond threaded section 406. The first threaded section 404 can matewith the second threaded section 406 on a retainer 408 or otherstructure. In the embodiment illustrated, the retainer 408 is coupled tocapsule tip 314. During use, an operator can lock (i.e., preventrelative axial movement between the tip 314 and guidewire 400) theguidewire 400 to tip 314 (or another structure) by rotating theguidewire 400 such that threaded section 404 mates with the threadedsection 406. Although illustrated as spaced apart from a distal tip 410of the distal end 402, threaded section 404 can alternatively be locatedat the distal tip 410 or spaced apart therefrom at various distances.

FIGS. 6A and 6B illustrate a first control state and a second controlstate, respectively, for an alternative embodiment to control the distalend 402 of guidewire 400. In the illustrated embodiment, the guidewire400 is disposed within a guidewire lumen 440. The tip 314 is coupledwith a guidewire control module 450 that includes a moving section 452,a stationary section 454 and a control mechanism 456. Collectively, themoving section 452 and stationary section 454 form a collet withinclined surfaces arranged such that, upon actuation of the movingsection 452 relative to the stationary section 454, a force is appliedto the guidewire 400 so as to prevent movement of the guidewire 400relative to tip 314. To apply this force, the control mechanism 456 isconnected with the handle 200 (not shown) and the moving section 452. Apulling force can be applied to the control mechanism in a directionaway from the tip 314, causing movement of the moving section 452relative to the stationary section 454. In the first control state ofFIG. 6A, the control module 450 is spaced apart from the distal end 402of the guidewire 400. In the second control state of FIG. 6B, after aforce has been applied to control mechanism 456, the control module 450transitions to the second control state, wherein the control module 450is in contact with the guidewire 400 and prevents movement between theguidewire 400 and the tip 314.

FIGS. 7A and 7B illustrate an alternative embodiment for controllingdistal end 402 of guidewire 400 disposed within a guidewire lumen 480. Aguidewire control module 500 (referenced generally) operates in a firstcontrol state (FIG. 7A), allowing movement between catheter 300 andguidewire 400, and a second control state (FIG. 7B), preventing movementbetween catheter 300 and guidewire 400. The control module 500 includesa contact surface 502, engagement member 504 and a tip control mechanism506. In the first control state of FIG. 7A, the contact surface 502 oftip 314 is adjacent to and/or engaging catheter 300. Engagement member504, disposed within the tip 314, is spaced apart from the guidewire400, allowing relative movement between the catheter 300 and theguidewire 400. Upon applying a force to the tip control mechanism 506relative to tip 314 (e.g., by pushing catheter 300 or pulling a proximalend of the tip control mechanism 506 coupled with handle 200), tip 314is compliant so as to be forced within the catheter 300.

As illustrated in FIG. 7B, contact surface 502 compresses the tip 314due to a size of the inner surface of the catheter 300. Thiscompression, in turn, places force on the engagement member 504.Ultimately, the engagement member 504 contacts the guidewire 400 andtransitions to the second control state where relative movement betweenthe guidewire 400 and the catheter 300 is prevented. A variety ofdifferent mechanisms can be integrated and/or coupled with engagementmember 504. For example, the engagement member 504 can include aprojection or other structure to grasp the guidewire 400 so as to assistholding the guidewire 400 relative to the catheter 300. In a furtherembodiment, engagement member 504 can provide tactile feedback to anoperator upon transitioning from the first control state of FIG. 7A tothe second control state of FIG. 7B.

In another embodiment, illustrated in FIGS. 8A and 8B, an alternativeguidewire control module 550 (referenced generally) includes aninflatable region 552 and a conduit 554 fluidly coupled with theinflatable region 552. In a first control state illustrated in FIG. 8A,a contact surface 556 of the inflatable region 552 is spaced apart fromthe guidewire 400, allowing relative movement between the catheter 300and the guidewire 400. To transition the guidewire control module 550 toa second control state, fluid (e.g., air) is provided through conduit554 to the inflatable region 552. Additional fluid within the inflatableregion 552 causes the inflatable region 552 to expand, as illustrated ina second control state of FIG. 8B. Expansion of the inflatable region552 causes contact surface 556 to engage guide wire 400. In the secondcontrol state, engagement of the contact surface 556 and guidewire 400prevents relative movement between the catheter 300/tip 314 and theguidewire 400. In the embodiment illustrated, inflatable region 552 isembodied as a toroid, although other shapes and configurations can beutilized. For example, the inflatable region 552 need not surround anentirety of the guidewire 400 and can be positioned on a single side ofthe guidewire 400.

FIGS. 9A and 9B illustrate another embodiment with a guidewire controlmodule 590 having inflatable regions 600 and 602 positioned on opposedsides of guidewire 400. Each inflatable region 600 and 602 is fluidlycoupled with a corresponding conduit 604 and 606, respectively. Theconduits 604, 606 are configured to provide fluid (e.g., air) torespective inflatable regions 600, 602 so as to independently inflate(i.e., increase a volume) the regions 600, 602. In a first control stateof the control module 590, illustrated in FIG. 9A, the inflatableregions 600 and 602 are spaced apart from the guidewire 400, allowingrelative movement between the catheter 300/tip 314 and the guidewire400. In a second control state of the control module 590, illustrated inFIG. 9B, region 602 has been inflated, increasing its volume such thatthe region 602 contacts the guidewire 400 and biases that portion of theguidewire 400 toward the opposite region 600. In the second controlstate, relative movement between the catheter 300/tip 314 and guidewire400 is prevented. Moreover, the guidewire 400 can be steered in aparticular direction as influenced by the inflatable region 602. In oneembodiment, inflation of region 602 will bias the distal end 402 of theguirewire 400 in a desired direction (e.g., angularly offset from apushing force applied to guidewire 400). As a result, control foradvancement of the guidewire 400 is achieved.

Although specific examples have been illustrated and described herein, avariety of alternate and/or equivalent implementations may besubstituted for the specific examples shown and described withoutdeparting from the scope of the present disclosure. This application isintended to cover any adaptations or variations of the specific examplesdiscussed herein. Therefore, it is intended that this disclosure belimited only by the claims and the equivalents thereof.

1. A delivery system, comprising: a guidewire; and a catheter assemblyincluding: a catheter device defining a proximal end, a distal endopposite the proximal end, and a guidewire lumen open to the distal endand sized to receive the guidewire, a handle attached to the proximalend, an inflatable member maintained within an interior of the catheterdevice proximate the distal end, wherein the inflatable member isconfigured to expand from a first state to a second state; wherein thesystem is configured such that with the guidewire disposed through theguidewire lumen, a restriction upon axial movement of the guidewirerelative to the catheter device by the inflatable member is greater inthe second state than in the first state.
 2. The delivery system ofclaim 1, wherein a surface of the inflatable member is exposed to theguidewire lumen.
 3. The delivery system of claim 1, wherein the systemis configured such that with the guidewire disposed through theguidewire lumen, a force applied by the inflatable member onto theguidewire is greater in the second state than in the first state.
 4. Thedelivery system of claim 1, wherein the system is configured such thatwith the guidewire disposed through the guidewire lumen, the inflatablemember prevents axial movement of the guidewire relative to the catheterdevice in the second state, and does not prevent axial movement of theguidewire relative to the catheter device in the first state.
 5. Thedelivery system of claim 1, wherein the catheter device further includesan inflation conduit fluidly open an interior of the inflatable member.6. The delivery system of claim 5, further comprising a source of fluidconnected to the inflation conduit, wherein the inflatable membertransitions from the first state to the second state with delivery offluid from the source of fluid via the inflation conduit.
 7. Thedelivery system of claim 1, wherein the inflatable member is configuredto surround a circumference of the guidewire when the guidewire isdisposed through the guidewire lumen.
 8. The delivery system of claim 1,wherein the catheter device defines a distal region terminating at thedistal end, and further wherein an outer diameter of the distal regiontapers to the distal end.
 9. The delivery system of claim 8, wherein atleast a portion of the inflatable member is proximal the distal region.